Job Details

HTI has an immediate opening for a Change Control Compliance Specialist with a large pharmaceutical manufacturing company in Greenville, SC. This is a full-time, direct hire, onsite, salaried position. Salary depends on education and experience, and the range is approximately $60,000 – 70,000 / year.

The Change Control Compliance Specialist plays a key role in supporting quality and compliance within a regulated pharmaceutical manufacturing environment. This position is responsible for managing change control activities from initiation through closure, ensuring compliance with cGMPs and internal quality standards. The role partners closely with cross-functional teams to assess, document, and implement changes while maintaining the integrity of the Quality Management System.

What We Offer

• A stable, regulated pharmaceutical environment with strong quality and compliance standards
• Ownership of the Change Control system within Quality Systems
• Cross-functional collaboration with manufacturing, packaging, and quality teams
• Exposure to audits, quality metrics, and continuous improvement initiatives
• Long-term growth potential within Quality Assurance

What You Need

• Bachelor's degree in a science-related field or equivalent experience
• 3–5 years of experience in Quality Assurance or Quality Systems within a regulated environment
• Hands-on experience managing change control processes in a cGMP setting
• Experience with electronic quality systems (TrackWise or similar preferred)
• Strong proficiency with Microsoft Office (Word, Excel, Outlook); Adobe and electronic signature workflows preferred
• Excellent attention to detail with strong organizational and time-management skills
• Clear written and verbal communication skills and the ability to work independently in a fast-paced environment

What Your Role Will Look Like

• Manage change control activities including initiation, review, approval, tracking, and closure
• Review change requests for completeness, compliance, and quality impact prior to workflow initiation
• Maintain electronic databases and logs for open, extended, closed, and canceled changes
• Coordinate cross-functional change activities and communicate status updates to stakeholders
• Perform compliance checks, document edits, and quality reviews of change control records
• Train and support end users on change control processes and documentation requirements
• Identify documentation discrepancies and provide quality oversight for document revisions and releases
• Maintain electronic master files, including insertion of approved documentation and removal of obsolete materials
• Review and route manufacturing and packaging batch records, specifications, and instructions for approval
• Support audits, maintain quality metrics, and provide backup support for related quality documentation activities